• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, adjusted the methodology and baseline used to calculate royalties paid by F. Hoffmann-La Roche Ltd., of Basel, Switzerland, for off-label autoimmune prescriptions of CellCept (oral mycophenolate mofetil). The adjustments are intended to more accurately track the use of CellCept in its approved transplant rejection indications and will not impact Aspreva's revenue projections for the year. The companies also amended Aspreva's CellCept license, calling for Aspreva to contribute to Roche's clinical development work in lupus nephritis in China and to reimburse Roche for certain pre-market development activities. The amendments will result in a third-quarter charge of $20 million for Aspreva, which restructured last month. (See BioWorld Today, July 27, 2007.)

• Callisto Pharmaceuticals Inc., of New York, said it will continue to remain listed with the American Stock Exchange while the firm is attempting to regain compliance with the listing standards. The company received notice in October 2006 that it had fallen below certain listing standards. Callisto's drug candidates in development include anticancer agents and products to treat gastrointestinal disorders. The firm's product Atiprimod is in a Phase II clinical trial in advanced carcinoid cancer patients, and in a Phase I/IIa human clinical trial in relapsed or refractory multiple myeloma patients.

• Cangene Corp., of Toronto, said that it completed delivery of the initial order for anthrax immune globulin, and that the drug has been received formally into the U.S. strategic national stockpile. The company can proceed to invoice for about one-third of the previously disclosed $18 million to $22 million total, with the remainder being invoiced soon, when delivery of the botulism toxin immune globulin has been completed.

• Catalent Pharma Solutions Inc., of Somerset, N.J., and ALK-Abello A/S, of Hørsholm, Denmark, have signed an agreement that will enable a substantial increase in Zydis oral dissolving tablet production capacity dedicated to ALK-Abello's immunotherapy products. Under the agreement, ALK-Abello will fund a new production line for current and future tablet-based allergy products, which will be based at Catalent's Swindon, UK facility. Commercial production on the new line currently is expected to begin in 2010.

• Cell Therapeutics Inc., of Seattle, has received a deficiency letter from Nasdaq indicating that the company's recently completed registered offering of Series C 3 percent convertible preferred stock and warrants did not comply with voting rights requirements in Nasdaq rules. The company responded by amending its articles of incorporation to adjust the conversion ratio of the series to reduce the number of votes that the holders of the Series C Preferred have because it increased the conversion price from $3.90 to $4.53 for purposes of the voting rights provision.

• Codexis Inc., of Redwood City, Calif., licensed intellectual property from the California Institute of Technology relating to the preparation and identification of drug metabolites. Codexis plans to use the technology, which is based on a family of diverse variants of bacterial cytochrome P450 enzymes, to create research and development tools to help drug companies more rapidly profile metabolites linked to toxicity or efficacy.

• High Throughput Genomics, of Tucson, Ariz., along with collaborator David Galbraith, a plant sciences professor at the University of Arizona, was awarded a two-year $2.2 million Science Foundation Arizona Strategic Research Group grant. Of that, $1 million will be awarded for the first year of the grant, with a second $1 million awarded based on achievements of specific milestones. The remaining $171,550 is designated for a UA institutional allowance. The collaboration aims at expanding and developing HTG's quantitative Nuclease Protection Assay platform into a high-density microarray to improve the quality and speed of biomarker and target identification, validation and subsequent screening and optimization of agricultural and pharmaceutical compounds.

• Immunicon Corp., of Huntingdon Valley, Pa., said it has entered into laboratory service and assay development agreements with Merck Serono, of Geneva. The agreements cover laboratory service testing and development of specialized biomarker assays based on circulating tumor cells within the scope of an early clinical drug study.

• Merck KGaA, of Darmstadt, Germany, said its Merck Serono division is evaluating whether or not to further develop matuzumab in metastatic colorectal cancer after the EGFR-targeted antibody failed to meet its efficacy endpoint in a Phase II clinical trial. Merck Serono and partner Takeda Pharmaceutical Co., of Osaka, Japan, are continuing to study matuzumab in other tumors such as non-small-cell lung cancer.

• Pharmion Corp., of Boulder, Colo., and collaborator MethylGene Inc., of Montreal, announced that the FDA has granted orphan drug status to MGCD0103, an orally administered histone deacetylase inhibitor for the treatment of Hodgkin's lymphoma. The compound currently is in two Phase I/II clinical trials, in combination with Vidaza for hematological malignancies and with Gemzar in solid tumors, and in four Phase II monotherapy clinical trials in hematological malignancies.

• Tikvah Therapeutics Inc., of Atlanta, licensed from Phase II Discovery Inc., of Cincinnati, worldwide rights to develop and commercialize LY156735 for the treatment of circadian rhythm, sleep disorders, depression and other potential indications. LY156735 is a second-generation melatonin agonist originally developed by Eli Lilly and Co., of Indianapolis, Phase II trials have demonstrated that the compound improves both objective and subjective sleep measures, while preclinical studies indicated its potential in treating depression. Terms of the deal were not disclosed. Separately, Tikvah established a collaboration with Families of Spinal Muscular Atrophy to advance development of the Phase II drug TIK-201, a formulation of sodium phenylbutyrate for SMA.